Synacthen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tetracosactide 0.25 mg/mL equivalent to tetracosactide hexaacetate 0.28 mg/ml

Available from:

Clinect NZ Pty Limited

INN (International Name):

Tetracosactide 0.25 mg/mL (= tetracosactide hexaacetate 0.28 mg/ml)

Dosage:

0.25 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Tetracosactide 0.25 mg/mL equivalent to tetracosactide hexaacetate 0.28 mg/ml Excipient: Acetic acid Sodium acetate trihydrate Sodium chloride Water for injection

Units in package:

Ampoule, glass, 1mL, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bachem AG

Therapeutic indications:

For the investigation of adrenocortical insufficiency

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, 1mL - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1969-12-31

Patient Information leaflet

1
New Zealand Consumer Medicine Information
SYNACTHEN I.M./I.V.

TETRACOSACTIDE HEXAACETATE
250 MICROGRAMS/ML SOLUTION FOR INJECTION OR INFUSION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Synacthen.
Read all of this leaflet carefully before you are given Synacthen
i.m./i.v.

It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you or your child
having Synacthen against the benefits they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
This medicine has been prescribed only for you. Do not give it to
anybody else or use it for
any other illnesses.
If any of the side effects affects you severely, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or pharmacist.
KEEP THIS LEAFLET. You may need to read it again.
WHAT SYNACTHEN IS AND WHAT IT IS USED FOR
WHAT SYNACTHEN IS
Synacthen belongs to a group of medicines called pituitary hormones
and analogues.
Synacthen is supplied as a liquid solution in a 1 mL colourless glass
ampoule.
Synacthen is given as an injection into a muscle or vein.
_WHAT SYNACTHEN IS USED FOR _
_ _
Synacthen is used as a diagnostic test to find out if the adrenal
glands, small glands next to
the kidneys, are working as well as they should.
Synacthen may also be used instead of steroids (medicines such as
cortisone) to treat a
number of different conditions:
•
acute exacerbations of multiple sclerosis.
•
some types of seizures in children.
2
•
rheumatic diseases as a short-term therapy in conditions for which
corticoids are normally
used.
•
skin diseases responsive to corticoids.
•
ulcerative colitis and Crohn’s disease.
•
additional therapy in cancer patients to improve the tolerability of
chemotherapy.
_HOW SYNACTHEN WORKS _
_ _
Synacthen works by stimulating the adrenal glands to increase the
production of natural
“st

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1
SYNACTHEN
I.M/I.V
®
(250
MICROGRAMS/ML)
SOLUTION
FOR
INJECTION OR INFUSION
The name of the medicine is Synacthen i.m/i.v ® (250 micrograms/mL)
solution for injection or infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tetracosactide hexaacetate 250micrograms/mL For full list of
excipients, see section 6.1
3
PHARMACEUTICALS FORM
Synacthen injection is a clear colourless aqueous solution for
intramuscular injection or intravenous infusion in
a 1 mL clear glass ampoule
_ACTIVE SUBSTANCE _
250 micrograms tetracosactide (beta
1-24
-corticotrophin) per ampoule (as hexaacetate).
_ACTIVE MOIETY _
Tetracosactide (beta
1-24
-corticotrophin).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_DIAGNOSTIC USE _
For the investigation of adrenocortical insufficiency.
_THERAPEUTIC USE _
Alternative to Synacthen Depot in the following indications where i.v.
injection or infusion of tetracosactide is
preferable to i.m. injection.
_Neurological diseases: _
•
Acute exacerbations in patients suffering from multiple sclerosis.
•
West syndrome (Infantile myoclonic encephalopathy with
hypsarrhythmia).
_Rheumatic diseases: _
Short-term therapy in conditions for which
•
glucocorticoids are normally indicated;
•
in patients showing poor gastrointestinal tolerance of oral
glucocorticoids;
•
where glucocorticoids in normal doses have not elicited an adequate
response.
2
_Skin diseases: _
Long-term treatment of skin disorders responsive to glucocorticoids -
e.g. pemphigus, severe chronic eczema,
erythrodermal or pustular forms of psoriasis.
_Diseases of the gastrointestinal tract _
•
Ulcerative colitis;
•
regional enteritis.
_Oncology _
As adjuvant therapy to improve the tolerability of chemotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DIAGNOSTIC USE _
_30-minute Synacthen test: _
Plasma cortisol is measured immediately before and exactly 30 minutes
after an injection of 250 micrograms
Synacthen i.m. or i.v. If plasma cortisol increases by >200 nmol/L (70
micrograms/L), i.e. if the value 30 m